Lower riskDrug recall · FDA · Published October 25, 2021
Sun Pharmaceutical Tadalafil Tablets 5mg Recall: Incorrect Crospovidone Formulation
Sun Pharmaceutical recalls 5mg Tadalafil tablets due to incorrect Crospovidone grade in manufacturing. This may affect safety but does not cause immediate harm. Check NDC #16714-075-01 and lot number DNC1127A.
“Sun Pharmaceutical Tadalafil Tablets 5mg Recall: Incorrect Crospovidone Formulation.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35637-sun-pharmaceutical-tadalafil-tablets-5mg-recall-incorrect-crospovidone-formulation. Based on FDA recall #D-0230-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0230-2022%22&limit=1).
The Food and Drug Administration announced on Oct. 25, 2021, that Sun Pharmaceutical Industries Inc. is recalling Tadalafil Tablets, USP 5 mg due to incorrect product formulation. The agency stated the recall was voluntary and initiated by the firm.
The recall involves an incorrect grade of Crospovidone used to manufacture the product. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Sun Pharmaceutical Industries Inc. has had 93 other recalls on record since May 21, 2013. Other recent recalls of similar products include Northstar Rx Recalls Tretinoin Cream Due to Impurities (Sept. 25, 2026), Sun Pharmaceutical Carbamazepine Tablets Recall (Aug. 3, 2026), and Sun Pharmaceutical Perampanel 6mg Tablets Recall (June 17, 2026). Other recent recalls of similar products include Shoolin Pharma Chem Tadalafil 500g Recall (Aug. 3, 2026), Shoolin Pharma Chem Sildenafil Recall (Aug. 3, 2026), and Shoolin Pharma Chem Tadalafil Recall (Aug. 3, 2026).
How to tell if you have this one
Check for the NDC number 16714-075-01 and lot number DNC1127A on the product label. The product is a 30-count bottle of 5mg Tadalafil tablets, prescription-only.
Brand
Sun Pharmaceutical
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Distributed to one distributor who may have further distribute the product nationwide.
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01; Lot # DNC1127A, exp. date 05/2023
73,957 30-count bottles
D-0231-2022
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01; Lot # DNC0814A, DNC0815A, Exp. Date 04/2023
36,786 30-count bottles
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC number 16714-075-01 and lot number DNC1127A on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed to one distributor who may have further distribute the product nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0230-2022 (October 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0230-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.